Protocol Number: 93-C-0133

Title:

Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Number:

93-C-0133

Summary:

5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Non-Hodgkin's lymphomas in the following categories: Diffuse large B cell, follicular center cell grade III, anaplastic large cell, and aggressive T-cell lymphomas. Burkitt and "Burkitt-like" lymphomas in patients greater than or equal to 18 years old.

Patients with evidence of an underlying low-grade lymphoma will not be eligible for this study. This includes patients who have both indolent and aggressive histologies in the same or different biopsy sites (e.g. large cell lymphoma in a node and follicular center cell lymphoma in the bone marrow).

Diagnosis confirmed by staff of Hematopathology Section, Laboratory of Pathology, NCI. Tissue blocks from patients treated in extramural sites must be forwarded to the NCI for analysis of bcl-2 by IHC and other markers within 1 month of study entry.

Stage and Prognosis of Patients: Stage II, III, IV for all subtypes , and stage I bulky (greater than 5 cm) primary mediastinal (e.g., thymic B-cell large cell lymphomas) and Burkitt and Burkitt-like lymphomas.

No prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).

HIV negative.

Not pregnant or nursing.

Adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater than 60 ml/min; bilirubin less than 1.5 mg/dl; ANC greater than 1,000 and platelets greater than 100,000) unless impairment is due to organ involvement by lymphoma.

No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.

No other serious concomitant medical illness or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety.

No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cervix cancer.

Ability to give informed consent.

Special Instructions:

Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.

Keywords:

Open-Label

Non-Randomized

Pilot

Recruitment Keywords:

None

Conditions:

Non Hodgkin's Lymphoma

Investigational Drug(s):

Rituximab

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

MACOP-B chemotherapy for the treatment of diffuse large-cell lymphoma

P-glycoprotein expression and schedule dependence of adriamycin cytotoxicity in human colon carcinoma cell lines

Advanced diffuse histiocytic lymphoma, a potentially curable disease

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